Tissue Allograft for Prostate Cancer

(RAP Trial)

Recruiting at 2 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: 5-phosphodiesterase inhibitors

Must not be taking: Immunosuppressants, Chemotherapy, Hormonal therapy

Disqualifiers: Obesity, Neurologic disorder, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Immediate (during surgery)

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MLG-Complete, a special tissue allograft made from perinatal tissue, to assist men who have undergone radical prostate surgery for localized prostate cancer. The study aims to reduce complications such as erectile dysfunction and urinary incontinence by protecting nerve bundles during the procedure. Men who may qualify for this trial have localized prostate cancer, plan to undergo nerve-sparing surgery, and do not currently have erectile dysfunction. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance post-surgery outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, chemotherapy, or hormonal therapy, you may not be eligible to participate.

What prior data suggests that this allograft is safe for prostate cancer patients?

Research has shown that perinatal tissue allografts, such as MLG-Complete, are generally safe for patients. Clinical studies found that these tissue wraps help patients recover more quickly, particularly in regaining bladder control and sexual function after prostate surgery. The FDA has approved the MLG-Complete allograft for use in various surgeries, indicating it is usually well-tolerated. Additionally, studies have not identified any serious side effects from this type of tissue wrap, making it a promising option for those undergoing prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, MLG-Complete offers a novel approach by using a tissue allograft specifically designed for nerve bundles. This allograft is administered quickly, in just five minutes, during a nerve-sparing robotic-assisted radical prostatectomy (RARP), aiming to protect nerve function and potentially improve post-surgical recovery. Researchers are excited because MLG-Complete could enhance surgical outcomes by preserving nerve integrity, which might lead to better quality of life for patients after surgery.

What evidence suggests that the MLG-Complete allograft is effective for improving complications after nerve-sparing RARP in prostate cancer?

Research has shown that using a perinatal tissue allograft like MLG-Complete during prostate surgery can aid recovery. In this trial, participants will receive the MLG-Complete allograft as part of supportive care. Studies have found that patients who received this type of membrane wrap often regained erectile function and urinary control more quickly. The allograft contains over 450 proteins, including growth factors that aid in healing and reduce inflammation. Additionally, a review of research confirms that these allografts can improve recovery after prostate surgery by enhancing these important functions. Overall, early findings suggest that MLG-Complete may effectively reduce complications after prostate surgery. ^{2 4 5 6 7}

Who Is on the Research Team?

Ram A. Pathak, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for men with localized prostate cancer who are undergoing nerve-sparing robot-assisted radical prostatectomy (RARP). It aims to see if wrapping nerves with a new tissue graft can reduce complications like erectile dysfunction and urinary incontinence after surgery.

Inclusion Criteria

Patient has the willingness to comply with follow-up surveys

Negative urinalysis within 30 days prior to date of surgery

Patient has no erectile dysfunction (SHIM score ≥ 19) prior to date of surgery

Exclusion Criteria

Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)

Patients with poor urinary control at baseline requiring the use of pads for leakage

Patients with obesity defined as body mass index (BMI) > 40 kg/m^2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of MLG-Complete allograft to nerve bundles during standard of care nerve-sparing RARP

Immediate (during surgery)

1 visit (in-person, surgical)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and continence

12 months

Multiple visits at 6 weeks, 3, 6, and 12 months post-RARP

Long-term follow-up

Extended monitoring for adverse events and quality of life changes

Up to 12 months post-RARP

What Are the Treatments Tested in This Trial?

Interventions

• MLG-Complete

Trial Overview

The intervention being tested is the use of MLG-Complete, a multi-layer perinatal tissue allograft, wrapped around nerves during RARP. The study will assess its feasibility and effectiveness in improving post-surgical outcomes compared to standard procedures.

How Is the Trial Designed?

Group I: Supportive care (MLG-Complete allograft) Experimental Treatment 2 Interventions

Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

jove.com

jove.com/v/68931/functional-oncologic-outcomes-following-perinatal-tissue-allograft

Functional and Oncologic Outcomes Following Perinatal ...

The study aims to evaluate the feasibility, safety, erectile function, and urinary continence recovery in patients with localized prostate ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11438271/

Preclinical and clinical evidence for using perinatal tissue ...

Clinical studies have shown that patients who receive an intra-operative prostatic perinatal membrane wrap have faster return to potency and continence.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05081232?term=AREA%5BBasicSearch%5D(umbilical%20cord%20allograft)&rank=10

Continence and Potency Following Multi-Layer Perinatal ...

MLG allografts contains more than 450 bioactive proteins including growth factors and cytokines known to modulate inflammation and promote tissue healing. MLG ...

4.

urotoday.com

urotoday.com/index.php?option=com_content&view=article&id=155833:preclinical-and-clinical-evidence-for-using-perinatal-tissue-allografts-in-nerve-sparing-robot-assisted-radical-prostatectomy-to-hasten-recovery-of-functional-outcomes-a-literature-review-beyond-the-abstract&catid=1134&utm_source=newsletter_13569&utm_medium=email&utm_campaign=uroalerts-oncology-daily&acm=_13569

A Literature Review - Beyond the Abstract

In conclusion, this review of current perinatal tissue allograft use in prostatectomy literature demonstrates that allograft use improves post- ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11394080/

Impact of Cryopreserved Placental Allografts on ...

Our data show improved continence recovery using CAM allografts. At a median follow-up of 41 months, there was no observed impact of BCR.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06940271

Feasibility and Effect of Wrapping Nerves With a Multi ...

This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after ...

7.

withpower.com

withpower.com/trial/phase-prostatic-neoplasms-4-2025-99c93

Tissue Allograft for Prostate Cancer (RAP Trial)

The RAP medical study, being run by Mayo Clinic, is evaluating whether MLG-Complete will have tolerable side effects & efficacy for patients with Prostate ...